Bruesewitz v. Wyeth

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Bruesewitz v. Wyeth by Mind Map: Bruesewitz v. Wyeth

1. Facts

1.1. Procedural History

1.1.1. Russell and Robalee Bruesewitz petitioned the vaccine court set up by the VICP

1.1.2. The VICP denied the claim

1.1.3. The Bruesewitz family challenged the vaccine court’s ruling by filing case in Pennsylvania state court claiming that the vaccine had a defective design that caused Hanna’s injuries

1.1.4. A federal judge dismissed the lawsuit, ruling that the NCVIA protected Wyeth from lawsuits based on vaccine injury claims

1.1.5. The U.S. Court of Appeals for the 3rd Circuit affirmed

1.1.6. The case was heard by the US Supreme court in 2010

1.2. What Happened

1.2.1. Prior to the Vaccine Injury Compensation Program (VICP), drug companies were withdrawing from the vaccine market due to increased exposure to law suits, putting the vaccine supply at risk. VICP was established as part of the National Childhood Vaccine Injury Act (NCVIA) in 1986.

1.2.2. Hannah Bruesewitz experienced seizures and permanent disabilities after receiving vaccinations manufactured by Wyeth. Hanna received a diphtheria-tetanus-pertussis vaccine when she was six months old

1.2.3. Russell and Robalee Bruesewitz alleged that the vaccine was the cause of Hanna’s injuries.

1.3. Parties

1.3.1. Bruesewitz Family (Russell Bruesewitz, et al.) Suit was brought on behalf of Russell and Robalee Bruesewitz’s daughter, Hannah

1.3.2. Wyeth, Inc. Wyeth is a Pharmaceutical company.  Before it was acquired by Pfizer, it was ranked #71 on the Fortune 500 in 1992.  In 1992 Wyeth had revenues of approximately $8B, $1.4B in profits, $7B of assets and a market capitalization of over $19B. Wyeth purchased Lederle Laboratories which manufactured the vaccine delivered to Hannah Bruesewitz

2. Issue Before the Court

2.1. Can a federal law shield a vaccine manufacturer from product liability lawsuits that seek damages for injury in cases where it is alleged that the injury could have been avoided if the vaccine had been designed better?

3. Rule of Law

3.1. VICP was established as part of NCVIA in 1986

3.1.1. VICP protects drug companies from certain claims

3.1.2. VICP states that pharmaceutical companies are not liable for vaccine-related injuries “if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.” 42 U.S.C. § 300aa-22(b)(1) (2006)

4. Application

4.1. Section 300aa–22(b)(1) “suggests that a vaccine’s design is not open to question in a tort action” (Supreme court opinion)

4.2. Technically speaking, a vaccine side effect could always be avoided if a different vaccine is used

4.3. Statute establishes that a side effect unavoidable if it is properly prepared and accompanied by proper directions and warnings

5. Conclusion

5.1. US Supreme Court affirmed

5.1.1. Justice Scalia delivered the opinion

5.1.2. Justices Roberts, Kennedy, Thomas, Breyer and Alito concurred. Sotamayor filed a dissenting opinion with Ginsburg joining. Kagan did not consider or participate in the decision

5.2. The rule applies to the facts

5.2.1. The vaccine was applied without directions and warnings

5.2.2. The injuries in that context were unavoidable

5.2.3. VICP provided protection in cases where side effects are unavoidable

6. Impact

6.1. Cases

6.1.1. MILIK V. SECRETARY OF HHS Claim that their son suffered severe neurological injuries as a result of (MMR) vaccination Miliks argued that Bruesewitz v. Wyeth was unconstitutional Miliks argued that Bruesewitz v. Wyeth does not prevent them from filing claim in Federal court The court stated that “Congress has the authority under the Supremacy Clause to preempt state law causes of action which conflict with the federal standards”

6.1.2. HOLMES v. MERCK & CO., INC Court deferred submission of the case pending resolution of Bruesewitz v. Wyeth Ninth Circuit U.S. Court of Appeals that parents’ claims were preempted by VICP, but noted that parents may pursue some state law claims

6.1.3. Grinage v. Mylan Plaintiff sued Mylan after her husband developed a fatal skin disease from taking Allopurino Bruesewitz v. Wyeth was cited by plaintiffs to show that courts recognize labeling defects as a “failure to warn”

6.1.4. Cases where the vaccine court has found for the plaintiffs BANKS, et al v. HHS 2007 - Defendants were awarded $810,000 when the court ruled that the measels-mumps-rubella (MMR) vaccine had caused acute brain damage that led to his autism spectrum disorder

6.2. Why Business Professionals Care

6.2.1. Despite overwhelming scientific evidence, parents cling to myths – such as vaccines causing autism This is due to the timing of the onset of the symptoms – often symptoms soon after a child receives a vaccination The vaccination mechanism is complex and not fully understood by the public When a child becomes sick, it is important to parents that the find the cause

6.2.2. Pharmaceutical companies can operate knowing that they’re protected from lawsuits based on coincidence and speculation

6.2.3. VICP is designed to protect the public by ensuring an adequate supply of vaccines produced by an innovative private sector

6.2.4. Legal frameworks like VICP can protect corporations from complex cases that are primarily driven by emotion

6.3. Current Business Practices

6.3.1. Journal of the American Medical Association published a report in 2015 where a study of over 95 thousand children showed that there was no causal link between MMR vaccinations and autism. It also showed that the vaccination rate of children with an older sibling diagnosed with autism were significantly lower (86% vs 92%). This is worth noting because this evidence validates VICP and along with VICP, promotes innovation.

6.3.2. Drug manufactures will continue to rely on Bruesewitz v. Wyeth. Because the designs of the vaccines can’t be challenged, drug companies can take vaccines to market after passing FDA approval with less risk.